Technical Field of Invention
The embodiments herein generally relate to a medical device and particularly relate to an LED based vaginal light therapy device for treatment of bacterial and fungal infections.
Description of Related Art
Vaginitis is characterized by the inflammation of the vagina that results in discharge, itching and pain. The cause is usually a change in the normal balance of vaginal bacteria or an infection. Vaginitis can also result from reduced estrogen levels after menopause. In a given year as many as 50% of the woman female population experiences bacterial or fungal infection within their vagina. The symptoms range from mucus like discharge, itching, aching, pain during intercourse to odor. The vaginal infections often have multiple causes that present challenging cases for treatment. It is critical to have a balance between naturally occurring yeast and bacteria. It is when the system is out of balance or other types of bacteria are present within the environment does one end up with vaginitis. Indeed, when one cause is treated, the other pathogens become resistant or get mutated when treated with anti-biotic and become resistant to anti-biotic therapies. Sometimes the reduction in good bacteria allows for a propagation of yeast, typically Candida albicans resulting in yeast infection. Further, either a change in pH balance or introduction of foreign bacteria in the vagina leads to infectious vaginitis. Physical factors that contribute to the development of an infection include the following: constantly wet vulva due to tight clothing, chemicals coming in contact with the vagina via scented tampons, antibiotics, birth control pills, or a diet favoring refined sugar and yeast.
Bacterial vaginosis also known as vaginal bacteriosis or Gardnerella Vaginitis is a disease of the vagina caused by excessive bacteria growth. Common symptoms include increased vaginal discharge that often smells fishlike. The discharge is usually white or gray in color. Burning with urination may also occur. Itching is uncommon. Occasionally there may be no symptoms. Having bacterial vaginosis increases the risk of infection by a number of other sexually transmitted infections including HIV/AIDS. It also increases the risk of early delivery among pregnant women. Bacterial vaginosis is caused by an imbalance of the naturally occurring bacteria in the vagina. Diagnosis is suspected based on the symptom and may be verified by testing the vaginal discharge and finding a higher than normal vaginal pH and large numbers of bacteria. Bacterial vaginosis is often confused with a vaginal yeast infection. Usually treatment is through the use of antibiotics. Bacterial vaginosis is the most common vaginal infection in women of reproductive age. The percentage of women affected at any given time varies between can be as high as 70%. Antibiotics, administered either orally or vaginally are effective in treatment. About 10% to 15% of people, however, do not improve with the first course of antibiotics and recurrence rates of up to 80% have been documented. Recurrence rates are increased with sexual activity with the same pre-post treatment partner and inconsistent condom use although estrogen-containing contraceptives decrease recurrence. There is evidence of an association between Bacterial vaginosis and increased rates of sexually transmitted infections such as HIV/AIDS. Bacterial vaginosis is associated with up to a six-fold increase of HIV shedding. There is also a correlation between the absence of vaginal lactobacilli and infection of Neisseria gonorrhoeae and Chlamydia trachomatis. Bacterial vaginosis is a risk factor for viral shedding and herpes virus type-2 infection. Bacterial vaginosis may increase the risk infection or reactivation of HPV.
Candidiasis, more commonly referred to as a Yeast Infection, is most commonly caused by an overgrowth of a fungus called Candida albicans in the vagina. Candida is yeast, a type of fungus. Yeast is always present in the vagina in small numbers, and symptoms only appear with overgrowth. Candida can multiply when an imbalance occurs, such as when the normal acidity of the vagina changes or when hormonal balance changes. Frequently occurring yeast infections may be a sign of more serious overarching health problem such as diabetes or a compromised immune system. Recurrent infections may also be due to use of antibiotic medications. Recurrent vulvovaginal candidiasis affects at least 75 million women annually in the U.S. About 5-8% of women experience four or more episodes per year, diagnosed as recurrent vulvovaginal candidiasis. About 70% of all premenopausal women develop thrush at some point in their lives. With the introduction of over-the-counter medications for home treatment of yeast infections, many women elect to self-diagnose and self-medicate, indicating that the true incidence of yeast infections annually may be significantly under-reported.
In comparison to antibacterial therapy, antifungal treatment is limited to a very small number of drug substances. Treatment for fungal infection can be topical or systemic. Topical antifungals are generally considered as first-line therapy for uncomplicated, superficial, relatively localized fungal infections due to their high efficacy and low potential for systemic adverse effects. Systemic antifungal agents are absorbed and delivered to the body through the blood stream. The oral route is usually the safest, the most economical, and the easiest route for systemic antifungal drugs.
Topical antifungal creams and suppositories have fewer side effects than oral antifungal medications because they aren't absorbed as readily, systemically by the body, and only exert a localized effect on the genital region. Antifungal pills affect the entire body, and side effects can include nausea, headaches, and abdominal pain. However, topical medications can be messy and uncomfortable, while pills are comparatively simple. Treatment using antifungal medication is ineffective in up to 20% of cases. Treatment for thrush is considered to have failed if the symptoms do not clear within 7-14 days. In addition, the incidence of resistance to antifungal agents may be increasing, with drug-resistant fungal strains becoming increasingly common causes of infection in high-risk patient groups such as HIV/AIDS patients. Accordingly, alternative antifungal strategies are being actively sought.
Severe forms of infection are hard to treat, and frequently require more aggressive and long-term therapy, as is the case with chronic, recurrent cases. Additionally, incomplete treatments often result in drug resistant infections therefore full course of therapy should be adhered to.
Alternative Treatment is using a device with a photo-sensitizing agent on yeast infection. In photodynamic antimicrobial chemotherapy (PACT), a combination of a sensitizing drug and visible light causes selective destruction of microbial cells. The ability of light—drug combinations to kill microorganisms has been known for over a century. However, it is only recently with the beginning of the search for alternative treatments for antibiotic-resistant pathogens that the phenomenon has been investigated in detail. Numerous studies have shown PACT to be highly effective in the in vitro destruction of viruses and protozoa, as well as Gram-positive and Gram-negative bacteria and fungi. Light radiation at certain wavelengths causes the death or retarded growth of fungal pathogens residing in human tissue. Reactive Oxygen Species (ROS) can be generated under light-tissue/fungi interaction. Light at certain wavelengths has high efficiency in stimulating generation of ROS in fungal infected areas. Higher power (as compared to traditional low light therapy) of light radiation and prolonged exposure time on tissue creates a fatal concentration of ROS, which is toxic to the pathogen, resulting the retardation or death of the fungi. Under the same circumstances of radiation, the light does not significantly affect healthy human tissue around the infected area. Light radiation only affects local tissue within the radiation zone and has no systemic toxicity.
The market for blue light therapy for micro-organism treatment is somewhat developed, with a number of players offering solutions that appear to offer similar core functionality to the proposed innovation, if somewhat different in form. However, none of the existing products other than the Denta-Ray are designed for use within a body cavity especially the oral cavity, and none of the identified products are designed to target fungal infections, and none are designed for use within the vagina.
While one of the prior arts discloses an intravaginal treatment device (ITD) that provides therapeutic light and fluid treatments. The ITD uses illumination to gather various types of imager data that is used to identify the condition, monitor the treatment process, and evaluate treatment efficacy. Specific frequency light emissions and associated fluids are used to reduce overabundant flora, at least assist in elimination of fungal, viral and bacterial invaders, and enhance the detection process. Several configurations and sizes of ITDs with light and fluid therapy, also have a built in optics assembly (camera, light sources, etc.) for capturing intravaginal still images and video of vaginal channels, cervix, cervical channels, uterus and fallopian tubes. Some ITD configurations are also wearable and include full fluid delivery infrastructure unlike some other ITDs with external components. Supporting devices include local and remotely located computing devices such as laptops, smart phones, and independent monitors. ITDs can be fully or partially inserted via the vaginal channel, and operate in a stand-alone mode or pursuant to remote control. Therapy procedures may be preset or programmed to deliver continuous, periodic and scheduled performance with various underlying parameters defined in the preset or programming processes.
Another prior art discloses a device for treating the-vaginal canal by a laser beam, comprising a vaginal canal wall retractor, associated to a system for directing the laser beam towards the wall. This allows using the laser beam for treating the mucosa of the vaginal canal. The main purpose of the treatment that may be performed with the device according to the invention is to prevent and treat atrophic vaginitis, a condition typical but not exclusive of the post-menopause period that currently is normally treated with estrogens for short periods. Atrophic vaginitis is a pathological condition characterized by an inflammation of the vaginal mucosa with progressive decrease of the mucosa thickness due to the loss of collagen structure.
Although, the light therapy treatment of various bacterial, fungal or viral infection in a vaginal canal is known in the prior arts but a treatment of the said infections is majorly achieved through chemical or drug therapies. A use of the said therapies affects an internal functioning of the vagina and uterus as the chemicals used in the form of paste or gel or liquid result in unwanted chemical reactions that are harsh or result in various complications. Also, the light therapy of such infections primarily used within the interior of the vaginal canal has to be achieved through a sophisticated and miniature device being failed to be disclosed or implemented by the known prior arts.
Oral antifungal medications carry the risk of significant side effects, and many patients are allergic to or intolerant of these drugs. Topical solutions can be messy and inconvenient. There are no existing products for the treatment of yeast infections without also requiring medication. Hence there is a need for a product that allows for the treatment of yeast and bacterial infections quickly and simply without systemic effects. With the continued and accelerating emergence of antibiotic-resistant microorganisms, there is burgeoning interest and investment in light therapy. A device that leverages this rising technology could potentially gain rapid acceptance in specific use cases as well as broader support among the general population simply wishing to avoid exposure to additional medications.
In the view of the foregoing, there is a need for a device to treat the intravaginal infections without creating any harmful side effects. Further there is a need for a simple device having a miniature size and the ability to manoeuvre the not-so-easily accessible areas in a vaginal canal.
The above mentioned shortcomings, disadvantages and problems are addressed herein, as detailed below.